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U.S. Department of Health and Human Services

Class 2 Device Recall Novation Crown Cup Connection GXL Neutral Liners

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 Class 2 Recall
Novation Crown Cup Connection GXL Neutral Liners
see related information
Date Posted February 05, 2013
Recall Status1 Terminated on December 24, 2013
Recall Number Z-0787-2013
Recall Event ID 64028
Premarket Notification
510(K) Number
K070479 
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented - Product Code LZO
Product Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.
Code Information Catalog No. 130-3253, Serial Numbers 2479944 - 2479969 and Catalog No. 136-32-53, Serial Numbers 2479873 - 2479898.
Recalling Firm/
Manufacturer
Exactech, Inc.
2320 NW 66th Ct
Gainesville, Florida 32653-1630
Manufacturer Reason
for Recall
Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Exactech, Inc. notified consignees by telephone on 11/05/12 of the affected devices and sent an "IMPORTANT PRODUCT RECALL NOTICE" letter dated 11/06/12. The letter describes the purpose of the recall, the product affected, the problem and actions to be taken by the consignees. A Product Recall Response Form was attached for the consignees to contact the Exactech inventory representative within 5 business days to confirm quantities of product in their inventory and return them to Exactech. Consignees with any questions relating to these devices should call 1-800-392-2832.
Quantity in Commerce 26 Units
Distribution Distributed in the states of TN, FL, VA, WA and NV.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LZO and Original Applicant = EXACTECH, INC.
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